Safety information announced by MHLW: Alert for the risk of severe hypocalcemia in patients who take RANMARK® (denosumab)

PMDA Request for Proper Use of Drugs

Date Title
New
September 11, 2012
PDF Alert for the risk of severe hypocalcemia in patients who take RANMARK® (denosumab) (PDF)
April 11, 2012 PDF Risk Management Plan Guidance (PDF)
February 14, 2012 PDF PFSB/SD Notification 0214-9 “Call attention to the Precautions of anti-influenza virus drugs” (PDF)
August 12, 2011 Press Release:
PDF Warnings and Alerting: Severe haemorrhages in patients treated with an anticoagulant “Prazaxa capsules(dabigatran etexilate)” (PDF)
August 2, 2011 PDF Risk Management Plan (RMP) Guidance (Draft) (PDF)
(This draft guidance was issued to invite public comment by MHLW)

http://search.e-gov.go.jp/servlet/Public?CLASSNAME=PCMMSTDETAIL&id=495110028&Mode=0
(Japanese text ONLY)

June. 23, 2011 PDF Safety Measures for diabetes medication “pioglitazone-containing products” (PDF)

Labeling change Annex (PDF)

March. 29, 2011 PDF < Q and A > (PDF)
Resuming vaccination with the pediatric pneumococcal conjugate vaccine and the Hib vaccine (Issued by the Tuberculosis and Infectious Disease Control Division, Health Service Bureau and Safety Division, Pharmaceutical and Food safety Bureau)

For Japanese: http://www.mhlw.go.jp/stf/houdou/2r98520000016yw1.html

PDF [Reference] (PDF)
Safety review results pneumococcal conjugate vaccine and Haemophilus influenza type b (Hib) vaccine foe pediatrics (Issued as on March 24th by the Joint meeting of subcommittee on Drug Safety and Vaccine Adverse Reaction Review Committee for Carcinoma of the Uterine Cervix)

For Japanese: http://www.mhlw.go.jp/stf/houdou/2r985200000167mx.html

PDF (List of Fatal Case Reports) (PDF)

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